Tooth whitening effect of whitening patch with primer
| ISRCTN | ISRCTN63650330 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63650330 |
| Secondary identifying numbers | KCT0004625 |
- Submission date
- 29/07/2020
- Registration date
- 20/08/2020
- Last edited
- 09/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The aim of this study is to evaluate the safety and tooth whitening effect of a tooth whitening patch with primer.
Who can participate?
Adults over 20 years of age with tooth discolouration
What does the study involve?
The effectiveness of whitening is confirmed by attaching a tooth whitening patch with primer for 30 minutes for 10 days. Safety is checked by examining the presence or absence of side effects caused by whitening through questionnaires and oral examinations.
What are the possible benefits and risks of participating?
Possible benefits include effective tooth whitening. Possible risks include gingival (gum) irritation and tooth tingling.
Where is the study run from?
Kyungpook National University (South Korea)
When is the study starting and how long is it expected to run for?
January 2019 to October 2019
Who is funding the study?
LG Household & Health Care Research Park (South Korea)
Who is the main contact?
Jin-kyoung Kim
jkk0621@dhc.ac.kr
Contact information
Public
Department of Preventive Dentistry
School of Dentistry
Kyungpook National University
2177, Dalgubeol-daero, Jung-gu
Daegu
41940
Korea, South
| Phone | +82 (0)53 660 6875 |
|---|---|
| jkk0621@dhc.ac.kr |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Scientific title | Clinical efficacy of bleaching patch with primer in randomized controlled trial |
| Study acronym | CEPT |
| Study objectives | To clinically evaluate the efficacy and safety of the primer that contains taurine and self-bleaching patches containing 3.0% hydrogen peroxide. |
| Ethics approval(s) | Approved 11/03/2019, Kyungpook National University Bioethics Review Committee (Department of preventive Dentistry School of Dentistry, Kyungpook National University 2177 Dalgubeol-daero, Jung-gu, Daegu 41940, Korea; +82 (0)53 2000 5430; knuiars@knu.ac.kr), ref: KNU 2019-0009 |
| Health condition(s) or problem(s) studied | Tooth whitening |
| Intervention | This is a double-blinded randomized clinical trial that referred to the Consolidated Standards of Reporting Trials (CONSORT) 2010 guideline from design to completion. Healthy adult applicants interested in tooth whitening are recruited through snowball sampling. The effectiveness of whitening is confirmed by attaching a patch containing 3.0% peroxide and a primer containing a mitigating component for 30 minutes for 10 days. In addition, safety is checked by examining the presence or absence of side effects caused by whitening through self-filling questionnaires and oral examinations. When applied for at least 30 minutes with a self-whitening patch containing 3.0% peroxide, the efficacy of whitening compared to the placebo-controlled group is confirmed, and the difference between application times of 30 minutes is confirmed. After applying the taurine-containing primer, a self-administered questionnaire completed asking about the patient's subjective symptoms and an oral examination is carried out for the side effects of whitening to confirm the clinical safety. Total duration of intervention and follow-up: 18/03/2019 to 26/04/2019. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hydrogen peroxide |
| Primary outcome measure | Current primary outcome measure as of 09/10/2020: Tooth color measured using ∆L, ∆a, ∆b and ∆E with Shade Eye NCC and Vita classical shade guide at baseline, 3, 5, 7 and 10 days _____ Previous primary outcome measure: Tooth color measured using ∆L, ∆a, ∆b with Shade Eye NCC and Vita classical shade guide at baseline, 3, 5, 7 and 10 days |
| Secondary outcome measures | Side effects measured using questionnaire, VAS scale and oral examination before patching and after 3, 5, 7 and 10 days |
| Overall study start date | 14/01/2019 |
| Completion date | 31/10/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 56 |
| Total final enrolment | 55 |
| Key inclusion criteria | 1. Adults over 20 years of age who agree to take the test 2. People with good general health and oral health 3. A person with six maxillary anterior teeth 4. A person with similar level of discoloration of each tooth showing proper tooth discoloration 5. A person who understands the purpose of the test and is able to read and write 6. Who can follow the test procedure and follow the visit schedule 7. Persons who can follow up during the test |
| Key exclusion criteria | 1. People with inadequate dentition in the practice of tooth whitening 2. People with resin and porcelain restorations in the anterior region 3. A person who shows signs of inflammation in teeth due to dental caries or dental erosion 4. People with hypersensitivity due to gingivitis and periodontitis 5. People with excessive discolouration due to drugs and congenital anomalies 6. Those who have experienced tooth whitening in the past and have not passed 3 years 7. Women who are pregnant, breastfeeding or have a pregnancy plan during the test 8. Other diseases that may affect the efficacy and safety evaluation of the drug 9. A person who is taking or administering medication 10. People participating in other clinical trials or human attachment tests 11. Anyone who can not communicate or follow instructions 12. Those who do not qualify for the test under the judgment of the other examiners |
| Date of first enrolment | 01/03/2019 |
| Date of final enrolment | 29/03/2019 |
Locations
Countries of recruitment
- Korea, South
Study participating centres
School of Dentistry
2177, Dalgubeol-daero, Jung-gu
Daegu
41940
Korea, South
Seoul
-
Korea, South
School of Science and Technology
2559, Gyeongsang-daero, Sangju-si, Gyeongsangbuk-do City
Sangju-si
37224
Korea, South
Sponsor information
University/education
Department of Preventive Dentistry
School of Dentistry
Daegu
41940
Korea, South
| Phone | +82 (0)53 660 6875 |
|---|---|
| jkk0621@dhc.ac.kr | |
| Website | http://www.knu.ac.kr/wbbs/ |
"ROR" |
https://ror.org/040c17130 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 08/09/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
09/10/2020: The following changes were made to the trial record:
1. The trial type was changed from Treatment to Quality of life.
2. The primary outcome measure was changed.
3. The trial participating centres "Daegu Health University, Busan Public Health Policy Institute" were removed.
10/08/2020: Trial's existence confirmed by Kyungpook National University Bioethics Review Committee.
